14 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293166·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111095085·F.O.MACINTOSH BLADE AM-STYLE 4
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112440·Awl Tap, 6.5 mm, Fixed Sleeve
BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 9, 2020
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 17, 2021
AVIATOR PLUS PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code LIT·January 14, 2014
ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·January 14, 2014
CAPSUREFIXNOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·April 22, 2013
PRESSURE MONITORING KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 27, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·July 9, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012